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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

DISCOGRAPHY KIT

Manufacturer

SPINAL SPECIALTIES, INC.

Date Cleared

1996-03-21

(70 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K033739,K043500,K051136

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY

Manufacturer

GE MEDICAL SYSTEMS

Date Cleared

1996-02-27

(42 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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